Post on 09-Jun-2020
transcript
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CARL LYONS Carl lives in Denmark
and has haemophilia A
US biopharmaceutical market
Eddie Williams
SVP, US Biopharmaceuticals
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:
• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto
• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures
• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
• Statements regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Be aware of the risk’ on p 42-43 of the Annual Report 2014 on the company’s website novonordisk.com.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise.
Important drug information
• Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only
• Saxenda® (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only
Capital Markets Day 2015 US biopharmaceutical market
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Novo Nordisk US biopharmaceutical history started with the launch of Norditropin® in 1997
1997 Norditropin® launch
2000 Norditropin® cartridge and NordiPen® delivery system introduction
2006
1997 2003
1999 NovoSeven® launch
2013 NovoSeven® RT MixPro™ Launch
2008 NovoSeven®
Room Temperature stable (RT) launch
2008
2010 2015
2003 Vagifem® and Activella® re-acquisition
Prof. Ulla Hedner University of Lund
2005 Norditropin®
NordiFlex™ launch
2015 Novoeight®
launch
2013 Norditropin® Storage Flexibility launch
2010 Norditropin® FlexPro® launch Turner Syndrome indication Vagifem® 10mcg launch
2015 Norditropin® FlexPro® 30mg launch FlexPro® Penmate® launch
2013
2010 NovoSeven® RT 8mg vial launch
2006 NovoSeven® Acquired Haemophilia indication
2014 NovoSeven® RT Glanzmanns Thrombasthenia indication Tretten®1 launch
2007 Norditropin®
Noonan Syndrome indication
1999
2007
2005 NovoSeven® FVII Deficiency indication
1 Tretten® is the brand name in the US and Canada. The European brand name is NovoThirteen®
Capital Markets Day 2015 US biopharmaceutical market
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• Launched 1999 • Market leader in bypassing agent segment • Treats patients across several rare bleeding disorders
• Launched Q2 2015 • Competitive label, including portability • Direct patient and health care professional engagement
• Launched Q2 2014 • Opportunity to demonstrate leadership in recombinant factor replacement therapy
• Launched 1997 • Value and volume leader in a clinically undifferentiated market
• Launched 2003 • Lower dose version launched 2010 • Growth challenged due to competition
US biopharmaceutical franchise
Capital Markets Day 2015 US biopharmaceutical market
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0.0
0.5
1.0
1.5
2.0
2.5
3.0
1 CAGR for 5-year period Note: Other biopharmaceuticals include Vagifem®, Activella® and Glucagen®
US biopharmaceutical reported sales Key market dynamics
US biopharmaceutical sales are growing high single digit
• Biopharmaceuticals sales growth driven by Norditropin® and Vagifem®
• Haemophilia sales historically driven by NovoSeven® RT
• Norditropin® strong growth driven by successful market access execution and preference for FlexPro® device
• Vagifem® performance driven by positive price development; generic Vagifem® expected in Q4 2016
Q3 2010
Q3 2015
DKK billion
CAGR1 +8.6%
Norditropin®
Haemophilia
Other biopharmaceuticals
Capital Markets Day 2015 US biopharmaceutical market
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Maintaining NovoSeven® RT market leadership through continued label expansion
1 Based on internal Novo Nordisk estimate Note: NovoSeven® RT is not approved for prophylactic use in the US
NovoSeven® RT US sales across indications1 US indications and key dynamics
NovoSeven® RT US indications
• Congenital Haemophilia with Inhibitors (CHwI)
• Surgery in CHwI
• Acquired Haemophilia (AH)
• Congenital Factor VII Deficiency
• Glanzmann’s Thrombasthenia
NovoSeven® RT key dynamics
• First and only recombinant bypassing agent
• Market value share leader, ~75%
• Small CHwI patient population, impacted by Immune Tolerance Induction (ITI) and clinical trial enrollment
Congenital Haemophilia
with Inhibitors (CHwI)
Surgery in CHwI
Acquired Haemophilia
(AH)
Congenital Factor VII Deficiency
Glanzmann’s Thrombasthenia
Capital Markets Day 2015 US biopharmaceutical market
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Switched from regimen Reason for switch
Source: Novo Nordisk data on file, 30 September 2015
Patients are primarily switching from prophylaxis regimen and due to portability US indications and key dynamics
Novoeight® launch is progressing as prophylaxis patients switch, primarily due to portability
Novoeight® US indications
• Adults and children with haemophilia A for:
• Control and prevention of bleeding
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Novoeight® key dynamics
• Effective patient engagement
• Product benefits resonating with patients and prescribers as patients shift to Novoeight® due to portability and reliability
Capital Markets Day 2015 US biopharmaceutical market
67%
31%
Prophylaxis On Demand
Unknown
64%
19%
13%
Portability Reliability
Company Purity
Other
Prophylaxis On Demand
Unknown
Portability
Company
Reliability
Purity
Other
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52%
0%
10%
20%
30%
40%
50%
60%
US growth hormone volume market share
Novo Nordisk continues to expand leadership within the growth hormone market in the US
Source: Novo Nordisk internal estimate based on specialty pharmacy data, weekly retail and weekly institutional data
1 Novo Nordisk internal estimate based on Company financial reports, Specialty pharmacy data, weekly retail and weekly institutional data
US indications and key dynamics
Sandoz
Roche
Eli Lilly Novo Nordisk Pfizer
Serono Teva/Ferring Norditropin® US indications
• Growth Hormone Deficiency (adult and paediatric)
• Noonan Syndrome
• Turner Syndrome
• Small for Gestational Age (SGA)
Norditropin® key dynamics
• Clinically undifferentiated market with seven players
• Key Norditropin® differentiators are temperature stability, FlexPro® device and support programmes
• Value market share of approximately 45%1
• Highly managed market by payors
• Submitted for potential expansion of indications: Idiopathic Short Stature and Prader Willi Syndrome
Sep 2011
Sep 2015
Capital Markets Day 2015 US biopharmaceutical market
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Concluding remarks
Maintain NovoSeven® RT market leadership
Drive continued solid uptake of Novoeight®
Continue expansion of Norditropin® market leadership
Capital Markets Day 2015 US biopharmaceutical market
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SCOTT WILLIAM UK Scott has haemophilia A
The Novo Nordisk biopharm pipeline
Mads Krogsgaard Thomsen
EVP & Chief Science Officer
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:
• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto
• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures
• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
• Statements regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Be aware of the risk’ on p 42-43 of the Annual Report 2014 on the company’s website novonordisk.com.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise.
Important drug information
• Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only
• Saxenda® (liraglutide 3 mg) is approve in the US and EU for the treatment of obesity only
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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Need to reduce disease and treatment burden
Potential advances in treatment outcomes and reduction of treatment burden
Significant unmet medical needs still exist in haemophilia
Raise the bar on treatment outcomes
Reduce the burden of treatment
Treatment burden
Dis
ease b
urd
en
Raise the bar on treatment outcomes
• Control bleeding and minimise pain
• Reduction and elimination of bleeds
• Protect joints: maintain joint function
Reduce the burden of treatment
• Less cumbersome administration
• Reduce dosing frequency
• Pursue less invasive administration
• Minimise risk of inhibitors
• Ensure portability of products
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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Novo Nordisk has a comprehensive biopharm portfolio
Phase 3 Launched2 Research/preclinical1 Phase 1 and 2
NovoSeven® N8-GP (NN7088) Long-acting rFVIII
N9-GP (NN7999) Long-acting rFIX
NovoEight®
Concizumab (NN7415) Monoclonal anti-TFPI
Bypassing agent
Replacement factor
Growth Hormone
Norditropin®
1 Illustrative, not representative for exact number of research projects. 2 HRT products excluded
Somapacitan (NN8640) Once-weekly GH
NovoThirteen® TRETTEN®
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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N9-GP phase 1 pharmacokinetics Paradigm 2 headline results (phase 3)
N9-GP administered once weekly reduces median bleeding rate to 1.0 episode per year in phase 3 trial
Source: Novo Nordisk Company Announcement, 17 May 2013
• Steady-state half-life of 110 hours
• Median bleeding rate for patients treated on demand was 15.6 episodes per year
• Patients on once-weekly prophylactic treatment had a median bleeding rate of 1.0 episode per year when treated with 40 IU/kg
• Among patients receiving 40 IU/kg: • 99% of bleeding episodes treated with only one infusion
• Two thirds of patients experienced complete resolution of bleeding into target joints
• N9-GP appeared to have a safe and well tolerated profile with no patients developing inhibitors
Next steps
• Submission of N9-GP in the US and Europe expected before end H1 2016
Dose normalised 50 IU/kg (N=15) One stage clot assay
FIX activity (IU/mL)
N9-GP pdFIX rFIX
1.2
1.0
0.8
0.6
0.4
0.2
0.0
168 0 24 48 72 96 120 144
Time (h)
Source: Negrier et al. Blood. 2011;115:2693-2701
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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N8-GP
Source: Tiede et al. J Thromb Haemot. 2013;11:670-675
N8-GP phase 1 pharmacokinetics Pathfinder 2 headline results (phase 3)1
N8-GP administered every fourth day reduces median bleeding rate to 1.3 episode per year in phase 3 trial
PK: pharmacokinetic; ABR: annualised bleeding rate; IU: international unit Source: 1 Novo Nordisk Company Announcement, 19 March 2014; 2 Novo Nordisk Company Announcement, 18 November 2015. 3 prophylaxis 75 IU/kg every 7 days (n=38) or prophylaxis 50 IU/kg every 4 days (n=17)
FVIII activity (IU/mL)
FVIII
Dose 50 IU/kg (n=8) One stage clot assay
168
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0 24 48 72 96 120 144
Time (h)
• PK documented single dose half-life of 18.4 hours and mean trough level before next dose of 8%
• Patients on every fourth day prophylaxis (50 IU/kg) had a median ABR of 1.3
• 95% of mild to moderate bleeds managed with 1-2 doses
• N8-GP appeared to have a safe and well tolerated profile
• One patient developed inhibitors, as expected in a population of previously treated haemophilia A patients
Pathfinder 2 extension trial results2
• 55 patients with ≤2 bleeds during 6 months in the main phase were randomised 2:1 to either once-weekly (75 IU/ kg) or every fourth day (50 IU/kg) treatment for 180 days3
• Patients in both treatment arms had a median ABR of 0
Next steps • Expansion of production capacity; US/EU submission 2018
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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Key characteristics of concizumab (NN7415) and phase 1b clinical trial
Concizumab (NN7415) has a promising pharmacokinetic profile
Concizumab has the potential to introduce a new paradigm in the treatment of haemophilia
• Anti-Tissue-Factor-Pathway-Inhibitor (anti-TFPI) is a new mechanism restoring thrombin generation in factor VIII and factor IX deficient patients, as well as inhibitor patients
• Mechanism without the risk of inhibitors
• Mechanism with potential for prophylaxis for all patients and convenient subcutaneous administration in a ready-to-use liquid formulation in a device
• Explorer 3 clinical trial initiated in Q3 2015:
• Phase 1b multiple dose, dose escalation trial in around 45 people with haemophilia A
• Investigates safety and PK/PD of concizumab administered subcutaneously
• Top line data expected in 2017
Healthy subjects 50 μg/kg
Healthy subjects 250 μg/kg
Healthy subjects 1000 μg/kg
Patients 1000 μg/kg
Patients 3000 μg/kg
PK: pharmacokinetic; PD: pharmacodynamic ELISA: Enzyme-linked immunosorbent assay. Explorer 1 trial; Source: Chowdary P, et al. XXIV congress of the ISTH 2013, Amsterdam. Abstract #2990
Concizumab ELISA (ng/mL)
Time since dose (days)
1,000,000
100,000
10,000
1,000
100
10
1
0.1
0 8 4 12 16 20 24 28 32 36 44 46
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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New factor VII analogue in preclinical development
Pharmacokinetics in nonhuman primates (clot activity)
NN7077, a new factor VII analogue, shows prolonged activity in animal studies
• NN7077 is a new potent factor VII analogue, currently in preclinical development as a prophylactic treatment for patients with inhibitors
• NN7077 has a 18-fold prolonged half-life in nonhuman
primates
• In vivo pharmacokinetic and duration-of-effect data
support a target product profile of every-other-day IV
dosing
• Clinical development planned to be initiated in 2017
Note: Pharmacokinetics in animals may vary significantly from pharmacokinetics in man Source: Novo Nordisk data on file Source: Novo Nordisk data on file
0 .1
1
1 0
1 0 0
T im e ( d a y s )
FV
II
a l
ev
el
(I
U/
ml)
1 .8 0 .2 h
m e a n S D ( n = 3 )
N N 7 0 7 7
3 4 .0 2 .0 h
FV IIa
1 2 3 4 5 6 7 8 9 1 0
2 0 0
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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NN8640 pharmacodynamic profile in adults with growth hormone deficiency (AGHD) Key characteristics of somapacitan (NN8640)
Somapacitan (NN8640) is a potent hGH derivative designed for once weekly dosing with an auto-injection pen
Note: Mean IGF-1 after four weekly doses of long-acting growth hormone in AGHD. Dashed lines indicate IGF-1 reference range (83 to 168 ng/mL); IGF-1: insulin-like growth factor 1. Source: Højby Rasmussen M et al, Poster presented at the 96th ENDO/16th ICE meeting 2014, LBSU-0377
hGH: human growth hormone; AGHD: adult growth hormone deficiency; GHD: growth hormone deficiency
• Somapacitan is a growth hormone derivative in development for treatment of GHD in children and adults via once weekly administration
• Potential for increased adherence to therapy
• Convenient subcutaneous administration of ‘ready-to-use’ liquid formulation in a device
• Low injection volume and small needle
• Phase 3 clinical trial initiated in Q4 2014:
• 280 drug naïve people with AGHD
• To investigate efficacy and safety of somapacitan administered once weekly
• Top line data expected in 2016
• A phase 2 trial in children with GHD is expected to be initiated in H1 2016
0.12 mg/kg/week 0.08 mg/kg/week
0.04 mg/kg/week 0.02 mg/kg/week
Norditropin®
IGF-1 (ng/ml)
0 1 2 3 4 5 6 7
500
400
300
200
100
0
600
Weeks
Capital Markets Day 2015 Novo Nordisk biopharm pipeline
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Concluding remarks
Regulatory submission of N9-GP in the US and Europe before end H1 2016
Concizumab represents a potential new paradigm in the treatment of haemophilia
Regulatory submission of N8-GP by 2018
Development of NN7077, a new factor VII analogue with potential for prophylaxis
Somapacitan represents a more convenient treatment option for people with growth disorders
Capital Markets Day 2015 Novo Nordisk biopharm pipeline